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The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation

18 Years
Open (Enrolling)
Human Papillomavirus Infections

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Trial Information

The Incidence, Prevalence and Genotype of Genital Human Papillomavirus Infections in Females Before and After Renal Transplantation

Each year about 800 renal transplantations are performed in the Netherlands. The current
immunosuppressive strategies have led to a 1-year patient and graft survival of more than
90%. This high survival rate urges medical specialists to pay increasing attention to the
long‐term side effects of immunosuppressive medication, such as virus‐associated cancers. An
example of an oncogenic virus is the high risk Human Papillomavirus (hrHPV) which is related
to (pre)malignancies of the anogenital tract e.g. cervix, vulva and anus. These malignancies
are among the most common malignancies in renal transplant recipients (RTRs). The incidence
of hrHPV‐related cervical and vulvar malignancies is increased up to a 100‐fold in RTRs
compared to the general population. There is limited literature on the exact behaviour of
HPV infection related anogenital (pre)malignancies in RTRs. A part of these
(pre)malignancies are probably already present at the time of transplantation while others
develop in the years after transplantation. With gynaecological examination the
investigators can diagnose anogenital (pre)malignancies before transplantation so treatment,
if necessary, can commence before transplantation. Knowledge about HPV status before and
after transplantation gives insight in the natural course of the HPV infection in this group
of patients and with this information the investigators can determine the value of
vaccination in patients waiting for renal transplantation in the future.

Inclusion Criteria:

- Female sex;

- Age ≥ 18 years at start of the study;

- Eligible for renal transplantation;

- Operation at the Radboud University Nijmegen Medical Centre;

- Signed informed consent;

- Mentally capable to understand and comprehend the study and its implications;

- Sufficient knowledge of the Dutch language to read, fully understand and complete the

Exclusion Criteria:

- Patient not willing to sign and/or return the informed consent form;

- Patient refusing additional treatment in case of abnormal findings at the first

- Patient being pregnant, or within a period of 3 months after delivery;

- Patient being within a period of 3 months after miscarriage.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Prevalence of genital HPV infection before and after renal transplantation in women with end stage renal disease

Outcome Description:

The difference between post-transplantation prevalence (two HPV tests in 6 months after transplantation)and pre-transplantation prevalence (two HPV tests in 6 months before transplantation) will be compared.

Outcome Time Frame:

6 months before and 6 months after renal transplantation

Safety Issue:


Principal Investigator

Joanne A de Hullu, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Medical Centre Nijmegen


Netherlands: Medical Ethics Review Committee (METC)

Study ID:




Start Date:

February 2012

Completion Date:

March 2015

Related Keywords:

  • Human Papillomavirus Infections
  • Human Papillomavirus
  • Renal transplantation
  • Warts
  • Papillomavirus Infections